Emgality is a calcitonin-gene related peptide antagonist.

Emgality is a prescription medicine used to prevent migraine headaches in adults.

Emgality is also used to treat cluster headache episodes in adults.

It is not known if Emgality is safe and effective in children.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Emgality if you are allergic to galcanezumab.

Emgality is not approved for use by anyone younger than 18 years old.

Tell your doctor if you are pregnant. It is not known whether galcanezumab will harm an unborn baby. However, having migraine headaches during pregnancy may cause preeclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of preventing migraines may outweigh any risks to the baby.

It may not be safe to breast-feed while using galcanezumab. Ask your doctor about any risk.

Use Emgality exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Emgality is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

For prevention of migraine headaches: Emgality is usually given as a first dose of 2 injections, followed by 1 injection once per month.

For treatment of a cluster headache episodes: Emgality is usually given as 3 injections at the start of the cluster period, followed by 1 injection once per month until the end of the cluster period.

Follow your doctor's dosing instructions very carefully.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Avoid injecting into skin that is hard, red, bruised, or tender.

Store this medicine in its original carton in the refrigerator, protected from light. Do not freeze or shake the medicine.

You may briefly store Emgality at room temperature. Protect from light and use the medicine within 7 days. Do not put it back in the refrigerator.

Take a syringe or injection pen out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose. Do not warm the syringe with hot water, sunlight, or a microwave.

Each prefilled syringe or injection pen is for one use only. Throw it away after one use, even if there is still medicine left inside.

Usual Adult Dose for Migraine Prophylaxis:

Initial dose: 240 mg subcutaneously once
Maintenance dose: 120 mg subcutaneously monthly

Comments:
-The first dose is a loading dose consisting of 2 consecutive subcutaneous injections of 120 mg each.
-If a dose is missed, administer as soon as possible. Thereafter, dose can be scheduled from the date of the last dose.

Use: For the preventive treatment of migraine.

Usual Adult Dose for Cluster Headache:

Dose: 300 mg (three consecutive subcutaneous injections of 100 mg each) at the onset of the cluster period, and then monthly until the end of the cluster period.

You should not use Emgality if you are allergic to galcanezumab.

Emgality is not approved for use by anyone younger than 18 years old.

Tell your doctor if you are pregnant. It is not known whether galcanezumab will harm an unborn baby. However, having migraine headaches during pregnancy may cause preeclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of preventing migraines may outweigh any risks to the baby.

It may not be safe to breast-feed while using galcanezumab. Ask your doctor about any risk.

Use the medicine as soon as you remember, and then restart your regular injection schedule 1 month later. Do not use two doses at one time to make up a missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Emgality: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

An allergic reaction to galcanezumab can occur several days after an injection.

Common side effects of Emgality may include:

• pain;
• redness;
• itching;
• irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with galcanezumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.